BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    X-TIP ANESTHESIA DELIVERY SYSTEM

    MDR report key: 2469198 · Received February 10, 2012

    Report

    Report Number
    2320721-2012-00006
    Event Type
    Malfunction
    Date Received
    February 10, 2012
    Date of Event
    December 8, 2011
    Report Date
    December 14, 2011
    Manufacturer
    DENTSPLY TULSA DENTAL SPECIALTIES
    Product Code
    DZM
    PMA / PMN Number
    K990511
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    WHILE NO SERIOUS INJURY RESULTED IN THIS EVENT, THERE HAS BEEN A PREVIOUS REPORT REC'D WITHIN THE LAST TWO YRS WHERE THIS MALFUNCTION RESULTED IN A SERIOUS INJURY. THEREFORE, THIS EVENT MEETS THE CRITERIA FOR REPORTABILITY PER 21 CFR PART 803. THE DEVICE IS AVAILABLE FOR EVAL, THOUGH RESULTS ARE NOT AVAILABLE AS OF THIS REPORT. EVAL RESULTS WILL BE SUBMITTED WHEN THEY BECOME AVAILABLE.

    Description of Event or Problem · 1

    IN THIS EVENT A DOCTOR REPORTED AN X-TIP SEPARATED IN THE HANDPIECE DURING USE. NO INJURY RESULTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 X-TIP ANESTHESIA DELIVERY SYSTEM DZM DENTSPLY TULSA DENTAL SPECIALTIES 07261000

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR